Drug

Pyrotinib

In clinical development

ClassReceptor protein-tyrosine kinase erbB-2 inhibitorEmerging researchLate-stage development

RxNorm2027921 ChEMBLCHEMBL3647420UNIICJN36EQM0H

Research papers

Active clinical trials

Protein targets

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Clinical trial2026-05-28Results expected Q4 2028 · ClinicalTrials.gov

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)

Clinical trial2026-05-28Results expected Q4 2027 · ClinicalTrials.gov

Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer

Clinical trial2026-05-20Results expected Q4 2031 · ClinicalTrials.gov

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

Clinical trial2026-04-21Results expected Q4 2027 · ClinicalTrials.gov

A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Clinical trial2026-04-01Results expected Q4 2028 · ClinicalTrials.gov

Efficacy and Safety of Pyrotinib in Combination With Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial

Clinical trial2026-02-27Primary completion · ClinicalTrials.gov

Efficacy and Safety of SHR-A1811 Versus Pyrotinib Plus Capecitabine in Patients With Trastuzumab Primary-Resistant HER2-Positive Advanced Breast Cancer：A Prospective, Multicenter, Open-Label, Randomized, Controlled Study

Clinical trial2026-02-18Results expected Q1 2029 · ClinicalTrials.gov

Neoadjuvant Therapy With Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab or Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab Sequenced With Paclitaxel-based Regimens + Trastuzumab + Pyrotinib in HER2+ Breast Cancer

Clinical trial2026-02-06Results expected Q3 2027 · ClinicalTrials.gov

Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial.

Research2023-10-31BMJ (Clinical research ed.)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Pyrotinib

RxNorm CUI

2027921

ChEMBL ID

CHEMBL3647420

UNII

CJN36EQM0H

Primary mechanism

Receptor protein-tyrosine kinase erbB-2 inhibitor

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Receptor tyrosine-protein kinase erbB-2

ERBB2 · P04626

INHIBITORReceptor protein-tyrosine kinase erbB-2 inhibitor

Epidermal growth factor receptor

EGFR · P00533

INHIBITOREpidermal growth factor receptor erbB1 inhibitor

Clinical trials

82 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 82

Phase 16Phase 1 / 24Phase 252Phase 2 / 32Phase 311Phase 42Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer

Not yet recruitingPH IVPeking University People's Hospitaln=5002031

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

RecruitingPH IVHebei Medical University Fourth Hospitaln=1002027

Adjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive and Lymph Node Negative Invasive Breast Cancer

Not yet recruitingPH IIIFudan Universityn=8762033

Disitamab Vedotin in Combination With Pyrotinib Versus THP in the First-line Treatment for HER2-positive Advanced Breast Cancer, a Multicentre, Randomized, Double-blind Controlled, Phase III Trial

RecruitingPH IIISun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=3122031

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial

RecruitingPH IIIRenJi Hospitaln=4882030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy

CompletedPH IIIJiangsu HengRui Medicine Co., Ltd.n=1512024

A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer

CompletedPH IIIJiangsu HengRui Medicine Co., Ltd.n=3552024

An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.

CompletedPH IJiangsu HengRui Medicine Co., Ltd.n=972023

A Single-centre, Open, Single-dose, Fixed-sequence Study to Investigate the Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects

CompletedPH IJiangsu HengRui Medicine Co., Ltd.n=362022

A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

CompletedPH IJiangsu HengRui Medicine Co., Ltd.n=182019

A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

CompletedPH IIJiangsu HengRui Medicine Co., Ltd.n=602019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

BMJ (Clinical research ed.) · 2023 · 79 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Docetaxel

Studied across the same disease area as Pyrotinib in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials